Cervical Cancer Screening with DNA-HPV Testing and Precancerous Lesions Detection: A Brazilian Population-based Demonstration Study / Rastreamento do câncer do colo do útero com teste de DNA-HPV e detecção de lesões precursoras: um estudo de demonstração de base populacional brasileiro

Abstract Objective To evaluate the rates of precancerous lesions, colposcopy referral, and positive predictive value (PPV) by age groups of a population-based screening with DNA-HPV testing. Methods The present demonstration study compared 16,384 HPV tests performed in the first 30 months of the program with 19,992 women tested in the cytology screening. The colposcopy referral rate and PPV for CIN2+ and CIN3+ by age group and screening program were compared. The statistical analysis used the chi-squared test and odds ratio (OR) with 95% confidence interval (95%CI). Results The HPV tests were 3.26% positive for HPV16-HPV18 and 9.92% positive for 12 other HPVs with a 3.7 times higher colposcopy referral rate than the cytology program, which had 1.68% abnormalities. Human Papillomavirus testing detected 103 CIN2, 89 CIN3, and one AIS, compared with 24 CIN2 and 54 CIN3 detected by cytology (p < 0.0001). The age group between 25 and 29 years old screened by HPV testing had 2.4 to 3.0 times more positivity, 13.0% colposcopy referral, twice more than women aged 30 to 39 years old (7.7%; p < 0.0001), and detected 20 CIN3 and 3 early-stage cancer versus 9 CIN3 and no cancer by cytology screening (CIN3 OR= 2.10; 95%CI: 0.91 -5.25; p = 0.043). The PPV of colposcopy for CIN2+ ranged from 29.5 to 41.0% in the HPV testing program. Conclusion There was a significant increase in detections of cervix precancerous lesions in a short period of screening with HPV testing. In women < 30 years old, the HPV testing exhibited more positivity, high colposcopy referral rate, similar colposcopy PPV to older women, and more detection of HSIL and early-stage cervical cancer.

Resumo Objetivo Avaliar as taxas de lesões pré-cancerosas, encaminhamento para colposco pia e valor preditivo positivo (VPP) por faixas etárias de rastreamento populacional com teste DNA-HPV. Métodos O presente estudo de demonstração comparou 16.384 testes de HPV realizados nos primeiros 30 meses do programa com 19.992 mulheres testadas no rastreio citológico. Os programas foram comparados por taxa de encaminhamento de colposcopia e VPP para NIC2+ e NIC3+ por faixa etária. A análise estatística utilizou o teste de qui-quadrado e odds ratio (OR, na sigla em inglês) com intervalo de confiança (IC) de 95%. Resultados Os testes de HPV foram 3,26% positivos para HPV16-HPV18 e 9,92% positivos para 12 outros HPVs, com uma taxa de encaminhamento de colposcopia 3,7 vezes maior do que o programa de citologia, que teve 1,68% de anormalidades. O teste de HPV detectou 103 NIC2, 89 NIC3 e um AIS, em comparação com 24 NIC2 e 54 NIC3 detectados por citologia (p < 0,0001 ). O rastreio por teste de HPV no grupo etário 25 a 29 anos teve 2,4 a 3,0 vezes mais positividade, 13,0% de encaminhamento para colposcopia, 2 vezes mais que mulheres de 30 a 39 anos (7,7%; p < 0,0001 ), e detectou 20 NIC3 e 3 cânceres em estágio inicial versus nove NIC3 e nenhum câncer pelo rastreio citológico (NIC3 OR= 2,10; 96%CI: 0,91 -5,25; p = 0,043). O VPP da colposcopia para NIC2+ variou de 29,5 a 41,0% no programa de teste de HPV. Conclusão Houve um aumento significativo na detecção de lesões pré-cancerosas do colo do útero em um curto período de rastreamento com teste de HPV. Em mulheres < 30 anos, o teste de HPV exibiu mais positividade, alta taxa de encaminhamento para colposcopia com VPP semelhante a mulheres mais velhas, e mais detecção de HSIL e de câncer cervical em estágio inicial.

Anal PAP, HPV tests and magnifying chromoendoscopy with biopsies in the diagnosis of anal intraephitelial neoplasia / Papanicolau anal, testes de HPV e cromoendoscopia de ampliação com biópsias no diagnóstico de neoplasia intraepitelial anal

Abstract Introduction: Anal intraepithelial neoplasia (AIN) is the most likely precursor of squamous cells cancer which represents 90% of anal cancers. The use of biomolecular tests as a screening method has been extended by gynecology. Given the similarities that exist between the HPV disease in the lower genital tract and anorectal sectors, it is expected that HPV tests can provide information for the diagnosis, treatment and follow-up for AIN-affected patients. Objectives: Comparing the performance of anal cytology, PAP and HPV tests (Hybrid Capture and Papillocheck) against the histology of the diagnosis of low- and high-grade AIN in risk groups. Material and methods: A cross-sectional study was carried out to evaluate diagnostic methods for low- and high-grade AIN in 73 patients. Samples for anal PAP, Papillocheck and Hybrid Capture were taken from all patients who then, regardless of the results, underwent magnifying chromoendoscopy (MCE) along with biopsy. Diagnostic test performances and their 95% confidence intervals (CI: 95%) were calculated as well as the likelihood ratio for each test. Results: Of the 73 patients, 49 (67%) were women. The average age of the patients was 38 years. In 38 patients (52%), the histology was positive with 10 (14%) grade II AIN or higher. There were no statistically significant differences in sensitivity nor in specificity for low- and high-grade AINs between any of the tests. Conclusion: Anal PAP, the Hybrid Capture test (HC2, Qiagen) and PapilloCheck (Greiner Bio One) were highly sensitive but not specific for low- and high-grade AINs. Therefore, a biopsy should be conducted against a positive result of any of the tests to confirm AIN and the degree of dysplasia. The screening method selection depend on the availability but also costs of the test should be considered, since all the diagnostic tests have similar performance.

Resumo Introdução: A neoplasia intraepitelial anal é o precursor mais provável do câncer de células escamosas, que representa 90% dos tumores anais. O uso de exames biomoleculares como método de triagem foi ampliado pela ginecologia. Considerando-se as semelhanças entre as apresentações de HPV no trato genital inferior e anorretal, espera-se que os exames de HPV possam fornecer informações para o diagnóstico, tratamento e acompanhamento dos pacientes com neoplasia intraepitelial anal. Objetivo: Comparar o desempenho da citologia anal, Papanicolau, exames para HPV (teste de captura híbrida e Papillocheck) e histologia no diagnóstico de neoplasia intraepitelial anal de baixo e alto grau em grupos de risco. Material e métodos: Foi realizado um estudo transversal para avaliar métodos de diagnóstico de neoplasia intraepitelial anal de baixo e alto grau em 73 pacientes. Amostras para Papanicolau anal, Papillocheck e captura híbrida foram coletadas de todos os pacientes; independentemente dos resultados desses exames, todos foram submetidos a cromoendoscopia de ampliação (CEA) e biópsia. O desempenho dos exames e seus intervalos de confiança de 95% (95% CI) foram calculados, bem como a razão de verossimilhança para cada teste. Resultados: Dos 73 pacientes, 49 (67%) eram mulheres. A idade média dos pacientes foi de 38 anos. A histologia foi positiva em 38 pacientes (52%), dos quais dez (14%) apresentaram neoplasia intraepitelial anal grau II ou superior. Não foram observadas diferenças estatisticamente significativas na sensibilidade ou especificidade para as neoplasias intraepiteliais anal de baixo e alto grau entre qualquer um dos exames. Conclusão: O Papanicolau anal, o teste de captura híbrida (HC2, Qiagen) e o Papillocheck (Greiner Bio One) foram altamente sensíveis, mas não específicos para neoplasia intraepitelial anal de baixo e alto grau. Portanto, uma biópsia deve ser realizada após um resultado positivo em qualquer um dos testes para confirmar o diagnóstico de neoplasia intraepitelial anal e seu grau. A seleção do método de triagem depende da disponibilidade, mas os custos devem ser considerados, uma vez que todos os testes apresentam desempenho semelhante.

Comparison of the PANArray HPV Genotyping Chip Test with the Cobas 4800 HPV and Hybrid Capture 2 Tests for Detection of HPV in ASCUS Women

PURPOSE: This study aimed to evaluate the performance of the PANArray human papilloma virus (HPV) test, a PCR-based DNA microarray assay, in detecting HPV from patient samples and its concordance with the cobas 4800 HPV and Hybrid Capture 2 (HC2) tests. MATERIALS AND METHODS: The PANArray HPV, cobas 4800 HPV, and HC2 tests were performed on 504 cervical swab samples from patients with atypical cells of undetermined significance at five hospitals. The samples that were interpreted as ‘HPV-other’ type positive in the PANArray HPV test were confirmed by direct sequencing. RESULTS: The concordance rates were 80.8% between the cobas 4800 HPV and PANArray HPV tests [κ=0.59, 95% confidence interval (CI) 0.52–0.66] and 80.2% (κ=0.6, 95% CI 0.55–0.68) between the HC2 and PANArray HPV tests. Among the 62 patients negative on PANArray HPV (defined as the absence of high risk HPV), but positive on both cobas 4800 HPV and HC2 tests, 42 (67.7%) tested positive for ‘HPV-other’ types on the PANArray HPV test, and 31 (50.0%) had gray zone results [relative light unit/control (RLU/CO), 1.4–9.25] in the HC2 test. Of the patients deemed positive by the PANArray HPV test, 43 tested positive for high-risk (HR) HPV in cobas 4800 HPV and HC 2 tests. Among them, 58.2% showed HR HPV, including HPV 16, by direct sequencing, of which 25% had gray results. CONCLUSION: Results classified as ‘HPV-other’ type by the PANArray HPV test, or gray zone results by HC2 (RLU/CO ratio level 1–10) should be carefully interpreted using comprehensive clinical information.

Test de virus papiloma humano como método de screening primario para el diagnóstico de neoplasias de cérvix uterino / Human papillomavirus test as a primary screening method for the diagnosis of uterine cervix neoplasms

La detección del cáncer cervicouterino mediante citología ha ido disminuyendo su incidencia en un 50%. Los métodos moleculares que detectan la presencia de HPV, consisten en la amplificación específica del DNA viral. La prueba de captura de Híbridos Hybrid Capture II (HC­II),(11), es un método semicuantitativo no radiactivo, basado en la hibridación del DNA de HPV con sondas de RNA, y en el que se usan anticuerpos monoclonales específicos que luego se revelan por quimioluminiscencia. A través de este método se detectaron cinco genotipos de bajo riesgo (6,11,42,43,44) y trece de alto riesgo (13,16,18,31,33,35,39,45,51,52,56,58,59 y 68). Objetivo: exponer test de HPV como método de cribado primario para diagnóstico temprano de genotipos de alto riesgo del HPV. Métodos: se realizó una revisión sobre el Test de virus papiloma humano como método de screening primario para el diagnóstico de neoplasias de cérvix uterino en Internet. La búsqueda abarcó artículos publicados en los últimos 10 años. Se consultaron las bases de datos de sistemas referativos, como MEDLINE, PubMed, Elsevier, Cochrane y SciELO con la utilización de varios descriptores tanto en inglés como en español. Se obtuvieron 27 artículos.

The detection of cervical cancer by cytology has been decreasing its incidence in a 50%. The molecular methods that detect the presence of HPV, consist of the specific amplification of viral DNA. The capture of Hybrid Capture II Hybrid (HC-II), (11), is a semi-quantitative non-radioactive method, based on the hybridization of HPV DNA with RNA probes, and in which specific monoclonal antibodies are used, are revealed by chemiluminescence. Five low-risk (6,11,42,43,44) and thirteen high-risk genotypes were detected through this method (13,16,18,31,33,35,39,45,51,52,56 , 58, 59 and 68) Objective: to present HPV test as a primary screening method for early diagnosis of HPV high-risk genotypes. Methods: a review was performed on the human papillomavirus test as a primary screening method for the diagnosis of uterine cervix neoplasms on the Internet. The search covered articles published in the last 10 years. Reference database databases such as MEDLINE, PubMed, Elsevier, Cochrane and SciELO were consulted using several descriptors in both English and Spanish. We obtained 27 articles.

Detección molecular del papilomavirus humano de alto riesgo en el seguimiento de mujeres tratadas por lesión escamosa intraepitelial / Molecular detection of high risk human papillomavirus in following women treated for squamous intraepithelial lesion

El cáncer de cuello uterino (CCU) es la primera causa de muerte por cáncer en mujeres en países en vías de desarrollo. La infección persistente por el virus papiloma humano (VPH) es un factor necesario en lesiones preneoplásicas y CCU. La citología cervicovaginal es el método mayormente utilizado para detectar el CCU y su uso combinado con la de detección de ADN viral seis meses post-tratamiento aumenta la efectividad para identificar mujeres tratadas con riesgo de lesión residual/recidiva. El objetivo fue describir la frecuencia de VPH de alto riesgo (AR) en mujeres tratadas por lesión escamosa intraepitelial (SIL) que acudieron al Servicio de Patología Cervical del Hospital San Pablo de enero-diciembre/2014. Se realizó un estudio descriptivo de corte transverso, que incluyó 80 pacientes que acudieron al servicio para control post-tratamiento por SIL. Se utilizó Cobas 4800 HPV Test (Roche) para la detección individual de VPH-16 y 18, y un pool de 10 VPH-AR (31,33,35,39,45,51,52,56,58,59) y dos de “probable” alto riesgo (66,68). Se encontró infección viral en el 7,5% (6/80) de las pacientes tratadas; identificándose VPH-16 en 3/6 de los casos positivos. En Paraguay existe alta incidencia de lesiones pre-neoplásicas y CCU siendo un problema de salud pública. Los datos observados sugieren que la utilización de este sistema para la detección viral puede llevar a optimizar el seguimiento post-tratamiento y la identificación de VPH-16 y 18 podría contribuir a la selección de pacientes en mayor riesgo de desarrollar una lesión cervical que deben someterse a una vigilancia frecuente y meticulosa.

Cervical cancer is the leading cause of cancer death in women in developing country.Persistent infection with human papillomavirus (HPV) is a necessary factor in premalignantlesions and cervical cancer. The Pap smear is the method most commonly used to detect thecervical cancer and its combined with the detection of viral DNA six months post-treatment increases effectiveness to identify women treated in risk with residual/recurrent lesion. Theaim was to describe the frequency of high-risk HPV (HR) in treated women for squamousintraepithelial lesion (SIL) who attended the Cervical Pathology Service of Hospital San Pablofrom January to December/2014. It is cross sectional, descriptive study which included 80patients who attended the service for post-treatment control. The 4800 Cobas HPV Test(Roche) was used, which detects HPV-16 and 18, and a pool of 10 HR-HPV(31,33,35,39,45,51,52,56,58,59) and two "probable" high risk (66,68). Viral infection wasfound in 7.5% (6/80) of patients treated; identifying HPV-16 in 3/6 of positive cases. InParaguay there is a high incidence of pre-neoplastic lesions and cervical cáncer remains apublic health problem. The observed data suggest that the use of this system for viraldetection can lead to optimize the post-treatment monitoring and the identification of HPV-16and 18 could contribute to the selection of patients at increased risk of developing cervicalinjury should undergo to frequent and careful monitoring.

Utilidad de la detección de virus papiloma de alto riesgo en pacientes con citología atípica y de neoplasia intraepitelial de bajo grado de cuello uterino

Antecedentes: La citología cervical atípica y de bajo grado son hallazgos frecuentes pero no siempre relevantes. Objetivo: Estudio prospectivo que analiza la utilidad de la determinación del virus papiloma humano (VPH) de alto riesgo, en detectar patología intraepitelial de alto grado. Método: 94 pacientes con citología atípica y 116 pacientes con citología de NIE 1 fueron evaluadas con la prueba de VPH de alto riesgo. Resultados: En pacientes con citología atípica, la prueba positiva de VPH identificó a 23% con patología de alto grado versus solo en 4% en aquellas con prueba negativa (p=0,0124). En pacientes con citología de NIE 1, la prueba positiva de VPH identificó a 13% con patología de alto grado versus en 5,5% en aquellas con prueba negativa (p=0,6923). Conclusiones: La determinación de presencia viral de alto riesgo es un examen útil en pacientes con citología atípica pero no contribuye en pacientes con citología de NIE 1.

Background: Atypical and low grade cervical cytology are frequent findings, however, not always relevant. Aims: Prospective study, that analyzes the usefulness of determining high risk human papilloma virus test (HPV), in detecting high grade intra epithelial neoplasia in these patients. Method: 94 patients with atypical cytology and 116 patients with CIN 1 cytology were evaluated with the high risk HPV test. Results: In patients with atypical cytology, a positive HPV test identified 23% with high grade CIN versus only in 4% when the test was negative (p=0.0124). In patients with CIN 1 cytology, a positive test identified 13% with high grade CIN versus 5.5% in those with a negative test (p=0.6923). Conclusion: High risk HPV determination is a useful test in patients with atypical cytology, however non contributory in patients with low grade CIN cytology.

Detección molecular del virus papiloma humano de alto riesgo oncogénico en muestras cervicales. laboratorio central de salud pública. primeros resultados / Molecular detection of high oncogenic risk human papiloma virus in cervical samples. central laboratory of public health. first results

El cáncer de cuello uterino es la primera causa de muerte por cáncer en mujeres en países en vías de desarrollo, con una tasa de incidencia de 34,2 por 100.000 mujeres y de mortalidad de 15,7 por 100.000 mujeres en Paraguay. La sensibilidad de la citología está entre 30-60%, mientras que la de la detección molecular del Virus Papiloma Humano (VPH) en muestras cervicales, es mayor al 90% para detectar neoplasia intraepitelial cervical de grado 2 (CIN II) o más. El objetivo de este trabajo fue describir la frecuencia de detección de VPH de alto riesgo (AR) y su distribución por edad en mujeres que concurrieron al Hospital San Pablo, de mayo a agosto de 2.013. Se estudiaron 170 muestras cervicales de pacientes que accedieron a participar firmando un consentimiento informado. Se utilizó el sistema Cobas 4800 HPV Test(Roche) que detecta los VPH-AR 16 y 18, y un pool de 10 VPH-AR (31,33,35,39,45,51,52,56,58,59) y dos de "probable" alto riesgo (66,68). La frecuencia de infección por VPH-AR fue del 16%, la infección decrecía con la edad y el mayor número de casos apareció en mujeres menores de 30 años. El VPH-16 fue encontrado en todos los grupos de edades. Este es el primer reporte de la detección de ADN de VPH-AR en el LCSP, y se muestra que la prevención y control del cáncer cérvico-uterino es una prioridad de salud pública en el país por la gran carga de la enfermedad evidenciada por su alta incidencia y mortalidad.

Cervical cancer is the leading cause of cancer death in women in developing countries,with an incidence rate of 34.2 per 100,000 women and 15.7 deaths per 100,000 womenin Paraguay. The sensitivity of cytology is 30-60% while molecular detection of HumanPapilloma Virus (HPV) in cervical samples is over 90% for cervical intraepithelial neoplasiagrade 2 (CIN II) or more. The aim of this study was to describe the frequency ofdetection of high-risk HPV (HR) and their distribution by age in women who attended theHospital San Pablo, from May to August 2013. One hundred seventy cervical samplesfrom patients who agreed to participate by signing an informed consent. The 4800 Cobassystem HPV Test (Roche), which detects the HR-HPV genotypes 16 and 18, a pool of 10 HR-HPV (31,33,35,39,45,51,52,56,58,59) and two "probable" high risk (66.68). Thefrequency of HR-HPV infection was 16%, the infection decreased with age and the highestnumber of cases occurred in women under 30 years. HPV-16 was found in all age groups.This is the first report about detection of DNA HR-HPV in the LCSP and it showed thatprevention and control of cervical cancer is a public health priority in the country by thelarge burden of the disease as evidenced by its high incidence and mortality.

Prevalence of high-risk human papillomavirus by cobas 4800 HPV test in urban Peru

Background: Molecular tests allow the detection of high-risk human papillomavirus in cervical samples, playing an important role in the prevention of cervical cancer. Objectives: We performed a study to determine the prevalence of HPV 16, HPV 18 and other high-risk human papillomavirus (pool 12 genotypes) in Peruvian females from diverse urban areas using the cobas 4800 HPV test. Methods: Routine cervical samples collected in our laboratory were analyzed by cobas 4800 HPV test. Results: A total of 2247 samples from female patients aged 17–79 years were tested. high-risk human papillomavirus was positive in 775 (34.49%) samples. Of these, 641 (82.71%) were single infections and 134 (17.29%) were multiple infections. The positivity rates for HPV 16, HPV 18, and other high-risk human papillomavirus were 10.77%, 2.0%, and 28.08%, respectively. In multiple high-risk human papillomavirus infections, the concomitance of HPV 16 and other high-risk human papillomavirus was more prevalent (13.42%). Conclusion: Our study showed high prevalence of high-risk human papillomavirus in urban Peru, mainly among young women. In both single and multiple infections other high-risk human papillomavirus were more prevalent than HPV 16 and HPV 18, which might influence vaccine impact in our country. Furthermore, the cobas 4800 HPV test may be considered a useful tool for HPV molecular diagnosis. .

Patrones de utilización de programas de prevención y diagnóstico temprano de cáncer en la mujer / Utilization patterns of prevention and early diagnosis for cancer in women

Objetivo. Estimar los patrones de utilización de los programas preventivos de cáncer en la mujer durante el periodo 2000-2012 en mujeres mexicanas que participaron en tres encuestas nacionales. Material y métodos. Se analizó información de la ENSA 2000 y de las ENSANUT 2006 y 2012 que son representativas de la población del país. Se obtuvieron prevalencias y se aplicaron pruebas de tendencia y regresión de Poisson para determinar las posibilidades de tener una mayor cobertura. Resultados. La cobertura de uso de Papanicolaou en los últimos 12 meses en 2012 fue de 45.5%, de prueba de VPH en los últimos cuatro años fue de 11.9% y de mastografía en los últimos dos años fue de 29.4 y de 17.2% en mujeres de 50 a 69 años y de 40 a 49 años, respectivamente. Conclusiones. Aunque se observa un incremento en la cobertura de los programas de detección se debe impulsar la calidad de los servicios y la cobertura universal.

Objective. To estimate the utilization patterns of cancer prevention programs in women during the period 2000-2012 in Mexican women who participated in three national surveys. Materials and methods. We analyzed data from the ENSA 2000, ENSANUT 2006 and ENSANUT 2012 that are representative of the Mexican population. Prevalences were obtained, trend tests and Poisson regression were used to determine the possibility of having more coverage. Results. The coverage of Papanicolaou use in the last 12 months in 2012 was 45.5%, HPV testing in the last four years was 11.9% and mammography use in the past two years was 29.4% and 17.2% in women aged 50-69 years and 40-49 years, respectively. Conclusions. Although there was an increase in the coverage of screening programs, there should be a boost in the service quality and universal coverage.

Comparison of the AMPLICOR human papillomavirus (HPV) Test and the Hybrid Capture 2 Assay for detection of high-risk HPV / 대한산부인과학회지

OBJECTIVE: The purpose of this study was to determine the efficacy of the AMPLICOR HPV test in comparison with the Hybrid Capture 2 (HC2) test in detecting HR HPV. METHODS: One hundred and fifty-three consecutive women attending the Colposcopy Clinic were included and cervical scrape specimens were tested for the presence of 13 HR HPV genotypes by both AMPLICOR HPV test and HC2 assay. RESULTS: The prevalence of HR HPV was 53/153 (34.6%) and 52/153 (34.0%) by AMPLICOR HPV test and HC2 assay, respectively. When discordant results were observed between AMPLICOR HPV test and HC2 assay, we used the HPV genotyping DNA chip and DNA sequence analysis, as reference standards. Concordant results were obtained for 128 (83.7%) of the 153 samples (Cohen's kappa=0.63, p<0.001). The genotyping showed that no HR HPV was detected in the 10 AMPLICOR negative HC2 positive samples, while HR HPV genotype was found in 3/13 (23.1%) AMPLICOR positive HC2 negative samples. The detection rates of HR HPV with AMPLICOR HPV test and HC2 assay were 38.7% and 48.4%, respectively, in CIN1; 95.0% and 100%, respectively, in CIN3/cancer. HPV positivity of AMPLICOR HPV test and HC2 assay increased linearly with the increasing grade of cytology or histology (p<0.001). In detecting high grade (CIN2+) lesions, sensitivities were 90.9% (CI, 75.9~97.0%), 95.5% (CI, 81.9~99.0%), respectively, for AMPLICOR HPV test and HC2 assay (p=1.00). The specificities of AMPLICOR HPV test and HC2 assay were 72.7% (CI, 64.3~79.8%) and 69.3% (CI, 60.7~76.7%), respectively (p=0.75). CONCLUSIONS: AMPLICOR HPV test is comparable to HC2 assay for detection of HR HPV, with similar sensitivity and specificity in detecting CIN2+ lesions. AMPLICOR HPV test can be considered clinically useful for detection of HR HPV. However, more data are clearly needed on the performance of AMPLICOR HPV test as a screening tool.